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IRCT20100706004329N5 IRCT 2018-02-06 Tehran University of Medical Sciences Soy Isoflavone on hot flushes, endometrial thickness and breast clinical and sonographic Effect of Soy Isoflavone on hot flushes, endometrial thickness and breast clinical and sonographic features 2015-05-01 anticipated 204 Complete https://irct.ir/trial/28536 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done systematically. based on days of the using the coin, it was determined that the intervention in the first day of this study was determined using the coin. Then, depending on the days of the week, the medicine or the placebo was prescribed respectively to eligible participate in the study Random allocation was performed by a methodologist. Medicines were placed in similar packets and list of random allocation of patients were not disclosed to dispensing practitioners. To conceal the random allocation process, a random 10-digit code corresponding to the identification number of the patient was written on each medicine packet. Every day epidemiologist give these packets to the dispensing nurse, who was unaware of the contents of each packet. When the doctor declared the eligibility of patients, the nurse gave packets to them according to the identification numbering, Blinding description: When the doctor declared the eligibility of patients, the nurse gave packets to them according to the identification numbering.The doctor evaluating the outcomes is a third person who is unaware of the random allocation process and type of treatment. To analyze the data, a statistician who is separate from the study process and who is unaware of all the processes performed will be used. 3 Hot flash. Intervention 1: Intervention group: received tablet Soyagol ( 50 mg isoflavone) ,Goldaru Pharmaceutical Company , one before lunch and one before dinner, for 12 weeks. Intervention 2: Control group: were given placebo resembling the active drug in size and shape in the same manner. One tablet before lunch and one before dinner, for 12 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is We had not thought about it but because the main data are available in the hospital and we will think about it in case there are requests
public Sadaf Alipour
Arash Women 's Hospital , Tehran University of Medical SciencesArash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse
Tehran Iran (Islamic Republic of) 1653915981 +98 21 7771 9922 sadafalipour@yahoo.com Tehran University of Medical Sciences scientific Sadaf Alipour
Arash Women 's Hospital , Tehran University of Medical SciencesArash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse
Tehran Iran (Islamic Republic of) 1653915981 +98 21 7771 9922 sadafalipour@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) over 40 years of age body mass index in range of 20-35Kg/m2 With hot flushes 40 years no limit Female Women with previous history of cancer,diabetes mellitus or renal, hepatic, and heart failure or abnormal uterine bleeding, mioma, ovarian cyst, Poly Cystic Ovarian syndrome(PCOS), endometriosis hormone therapy during the last three months, Patients with disability or known history of drug or alcohol consumption Cigarette smoking and caffeine consumption Treatment - Drugs Placebo Intervention group: received tablet Soyagol ( 50 mg isoflavone) ,Goldaru Pharmaceutical Company , one before lunch and one before dinner, for 12 weeks. Control group: were given placebo resembling the active drug in size and shape in the same manner. One tablet before lunch and one before dinner, for 12 weeks. Hot flashing were categorized in mild, moderate and severe. Timepoint: before and 6 and 12 months after intervention. Method of measurement: questionnaire. Endometrial thickness. Timepoint: Before and 6, 12 months after intervention. Method of measurement: Endometrial thickness was evaluated using ulthrasonography. Breast changes. Timepoint: Before and 6, 12 months after intervention. Method of measurement: Breast sonography. Tehran University of Medical Sciences Approved 2015-04-29 Ethics committee of Tehran University of Medical Sciences Qods St, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)